BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    OMNITECH FULGURATING ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIMEX 2

    FDA 510(k)
    FDA Class 2 ·Dental

    THE ALBERTA LENS SM2, SULFOCON B

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BASIS¿ SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 10, 2013

    REMAN BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 15, 2011

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015